Effects of Textured Insoles on Balance, Physical Performance, and Plantar Pressure in Older Adults With Knee Osteoarthritis

Официальное название

Investigation of the Effects of Lateral Wedge Textured Insoles on Balance, Physical Performance, and Plantar Pressure Distribution in Older Adults With Medial Knee Osteoarthritis

Обзор

This study aims to investigate the effects of textured insoles on balance, physical performance, and plantar pressure distribution in older adults with medial compartment knee osteoarthritis. Participants will be randomly assigned to two groups: the intervention group will receive textured insoles, while the control group will receive flat insoles without texture. Both groups will use their respective insoles for 4 weeks in their daily life. The study includes pre- and post-intervention assessments using balance platforms, functional performance tests (such as the Timed Up and Go, 30-second Chair Stand Test, and Step Test), and plantar pressure analysis. This randomized controlled study is designed to evaluate the effectiveness of textured insoles as a non-invasive and easily applicable rehabilitation method in improving balance and pressure distribution in elderly individuals with knee osteoarthritis.

Подробное описание

This randomized controlled trial will include older adults aged 65 and over who have been diagnosed with medial compartment knee osteoarthritis according to the American College of Rheumatology criteria and have radiological evidence (Kellgren-Lawrence grade 2 or 3).

Eligible participants will be randomly assigned into two groups: a textured insole group and a flat insole group. Participants will wear the insoles in their daily footwear for a period of 4 weeks.

Baseline and follow-up assessments will include:

* Static and dynamic plantar pressure distribution using the Diasu® baropodometric system. * Balance assessment using the HUR Smart Balance platform under four conditions (eyes open, eyes closed, eyes open on unstable surface, eyes closed on unstable surface). * Functional performance tests: Timed Up and Go (TUG), 30-second Chair Stand Test, and Step Test. * Disease-specific questionnaires: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Knee Injury and Osteoarthritis Outcome Score (KOOS). * Q-angle and knee proprioception measurement. Data will be analyzed to determine whether the use of textured insoles improves balance, physical performance, and plantar pressure distribution more effectively than flat insoles in older individuals with knee osteoarthritis.

Вмешательства

• Устройство Textured lateral wedge insole
  Participants in the experimental group will wear custom-designed textured lateral wedge insoles made from EVA material. These insoles incorporate lateral wedging to offload the medial knee compartment and a textured surface to enhance plantar sensory input. Participants will use the insoles during daily activities for a period of 8 weeks, with no additional intervention or exercise protocol.
• Устройство Use of lateral wedge flat insole
  Participants in this arm will use a customized lateral wedge flat insole with the same lateral inclination as the experimental insole but without any textured surface. This design allows for controlling the mechanical effect of the wedge while eliminating additional sensory stimulation.

Первичные конечные точки

• Change in 30-Second Chair Stand Test Performance [Срок оценки: 8 weeks]
• Change in Timed Up and Go (TUG) Test Performance [Срок оценки: 8 weeks]
• Change in Step Test Performance [Срок оценки: 8 weeks]
• Change in Static Balance Score [Срок оценки: 8 weeks]
• Change in Proprioception Disturbance Score [Срок оценки: 8 weeks]
• Change in Visual Dependency Score [Срок оценки: 8 weeks]
• Change in Left-Right Weight Distribution [Срок оценки: 8 weeks]
• Change in Peak Plantar Pressure [Срок оценки: 8 weeks]
• Change in Plantar Contact Area [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

• Aged between 65 and 75 years
• Diagnosed with medial compartment knee osteoarthritis
• Able to walk independently without assistive devices
• Having foot size compatible with available insole sizes
• Volunteering to participate in the study and providing informed consent

Критерии исключения

• Diagnosed with neurological diseases (e.g., stroke, Parkinson's disease, multiple sclerosis)
• Diagnosed with vestibular disorders or balance problems due to inner ear issues
• Having a history of lower extremity surgery in the past year
• Severe foot deformity that prevents insole use
• Having visual impairment that is not corrected with glasses
• Currently using a walking aid (cane, walker, etc.)
• Cognitive impairment or inability to follow instructions

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07097649 · LHU-TEXTINSOLE-2025-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗